penn microbiome therapy (pmt) for severe-clostridium difficile infection (cdi)

Conditions: Severe Clostridium Difficile Infection; Severe-Complicated/Fulminant Clostridium Difficile Infection

Summary: this is a randomized, open label, comparative, phase ii study to determine whether fecal microbiota transplant using penn microbiome therapy products helps standard therapy to treat severe clostridium difficile infection (c diff).


Eligibility criteria:
inclusion criteria: * 1. one or more episodes of cdi with symptoms including bowel movements altered in frequency or consistency from baseline. * 2. stool test positive for clostridium difficile by enzyme immunoassay (eia) by fda-cleared assay within 7 days prior to enrollment. * 3. age ≥ 18 years * 4. meets any one of the listed criteria for severe or severe-complicated/fulminant disease within 72 hours of enrollment. * 5. receiving antibiotic treatment for s/sc(severe-complicatedcategory)/f-cdi per current infectious diseases society of america(idsa) guidelines. enrollment criteria details: * 1. must either meet ≥1 criteria in severe category or in severe complicated category to be enrolled * 2. if the subject meets criteria in both categories, stratify to the higher severity category (severe complicated) * 3. detailed enrollment criteria definitions: * a. white blood cells (wbc) ≥15,000 cells/ul - if any value in the time period meets this definition * b. hypotension with systolic blood pressure sustained \< 90mmhg for three or more hours or requiring vasopressors (epinephrine, norepinephrine, phenylephrine, or vasopressin) * c. acute kidney injury - increase in serum creatinine level by ≥50% or new dialysis initiation * i. if a baseline serum creatinine value is not available, acute kidney injury will be defined as a serum creatinine \>1.5 mg/dl * d. temperature ≥38.5 °c or \<35.6°c - one value needed in time period - * e. ileus, bowel dilation or megacolon * i. ileus: if noted in any provider documentation or problem list (search words "ileus") or * ii. if the words "dilated" "dilation" or "ileus" are noted in a radiology report on intestines/colon, or if "megacolon" noted * f. lactate \>2.2 mmol/l - if any value in the time period meets this definition * g. systemic inflammatory response syndrome(sirs) criteria * i. heart rate \> 90 beats per minute * ii. respiratory rate \> 20 breaths per minute or paco2 \< 32 mmhg * iii. temperature \>38ºc or \<36ºc * iv. wbc \> 12,000 cells/ul, \ 10% immature (band) forms exclusion criteria: * 1. evidence of colon/small bowel perforation at the time of study screening. * 2. goals of care are directed to comfort rather than curative measures. * 3. moderate (anc \< 1000 cells/ul) or severe (anc \< 500 cells/ul) neutropenia. * 4. known food allergy that could lead to anaphylaxis. * 5. pregnancy * a. for subjects of childbearing potential (ages 18 to 55), the subject must have a negative urine pregnancy test within 48 hours of consent and no more than 48 hours prior to first product administration. * 6 receipt of fecal microbiota transplantation (fmt) or enrollment in a clinical trial for fmt within the last 3 months. * 7 covid-19 infection, as defined by a positive nucleic acid or antigen test within the prior 14 days and symptoms consistent with covid-19 infection